Effect of Probiotics on Endurance Athletes' Microbiome at Rest and Post-race

Gut Microbiota Clinical Trial

Official title:

Effect of Probiotics on Endurance Athletes' Microbiome at Rest and Post-race

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615961
• Other study ID #: 021/SPS/051
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: November 2022
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is intended to investigate the use of probiotics (LAB4 probiotics, Cultech, Port Talbot, Wales, UK) and the effect this has on gastrointestinal symptoms experienced during elite long-distance triathlon (ironman) competition, as well as the composition of the gut bacteria in the athlete.

Long-distance triathlon events frequently induce gastrointestinal discomfort due to the duration of the event (8-17 hours), the intensity of the exercise and the ingestion of large amounts of sugars throughout the event.

Data will be collected from athletes participating at the Kona ironman World-championships. Participants will supplement with either probiotic tablet, or placebo (sugar-pill) for 4-weeks prior to competition.

Athletes will be both male and female age-group athletes from any qualifying age category (age categories are as follows: 18-24; 25-29; 30-34; 35-39; 40-44; 45-49; 50-54; 55-59; 60-64; 65-69; 70-74; 75-79; 80-84).

The main investigation of the study will be the occurence/frequency/severity of gastrointestinal symptoms during training and competition between groups.

Description:

The study will recruit ironman triathletes who have qualified for the Kona ironman World-championships in Hawaii. Participants will be allocated into either probiotic (Lab4 Probiotics, Cultech, Port Talbot, Wales, UK) or placebo (Maltodextrin) groups, in a double-blind fashion (Blinded by supplement supplier).

Those recruited into the study will have their training load and gut symptoms monitored for 8-weeks prior to competition via the completion of online questionnaires (previously validated).

Four-weeks prior to competition participants will provide a stool sample for microbiome analysis, they will then proceed to supplement with probiotic or placebo for 4-weeks. 24-h prior to competition they will provide a stool sample as well as providing a sample from the first bowel movement post-race, which will be used for microbiome analysis.

Data will be collected for pre-race and raceday nutrition, as well as outcome measures for raceday performance and gastroitestinal symptoms experienced, again via online questionnaire.

Stool samples will be analysed by an independent laboratory that specialises in microbiome analysis.

Primary outcome measures will be the composition of the gut bacteria and the metabolites (substances produced) of the gut bacteria at baseline, pre-race and post-race. As well as the occurrence (frequency, duration, severity) of gastrointestinal symptoms during training and competition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Aged 18-85

• Qualification for the Kona Ironman World-championships in Hawaii

Exclusion Criteria:

• Have a current musculoskeletal injury.

• Currently unwell with cold or flu

• Have been told they have liver disease

• Have gastric Ulcer or other gastric/stomach problems

• Have a condition/disease of the Gut/bowel.

• Have diagnosed uncontrolled asthma

• Have kidney problems

• Have a chronic connective tissue disorder

• Have suffered cerebrovascular disease such as a stroke

• Are taking balcofen, methotrexate, tacrolimus and voriconazole, beta-blockers or diuretics drugs

Related Conditions & MeSH terms

• Aerobic Exercise
• Athletes
• Gut Microbiome
• Gut Microbiota
• Probiotics

Intervention

Dietary Supplement:
• Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK)
The intervention is a unique blend of probiotic cultures from a well-established manufacturer.
• Placebo
Placebo Tablets

Locations

Country	Name	City	State
United Kingdom	Liverpool John Moores University	Liverpool	Merseyside

Sponsors (3)

Lead Sponsor	Collaborator
Liverpool John Moores University	Georgia Southern University, University of Illinois at Chicago

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composition of the gut microbiome	This will assess the bacterial content in the gut of the participants, performed using shotgun metagenomic sequencing	4-weeks
Primary	Gastrointestinal symptoms during training and competition	This will be the subjective assessment of any gastrointestinal symptoms experienced during training and competition, from a previously validated questionnaire	8-weeks
Secondary	Training volume and intensity	This will be a quantification of the amount of training completed in the 8 weeks leading up to the race, via questionnaire.	8-weeks
Secondary	Perceived stress	This will be the subjective assessment of how stressed participants are in the 8 weeks leading up to competition, via questionnaire.	8-weeks
Secondary	Quality of sleep	This will be a subjective assessment of how well-rested the participants are in the 8 weeks leading up to competition, via questionnaire.	8-weeks